Quality Systems Specialist
TraceLink, Inc(11 days ago)
About this role
The Product Quality Specialist at TraceLink ensures the company’s life sciences applications and services meet applicable global regulations, standards, and customer requirements. The role functions as embedded independent oversight within the Software Development Lifecycle to maintain product quality, compliance, and readiness for customer release.
Required Skills
- Software Validation
- Risk Management
- CAPA
- Root Cause Analysis
- IQ/OQ
- SDLC
- Quality Assurance
- Regulatory Compliance
- Auditing
- AWS
Qualifications
- BS in Engineering
- BS in Computer Science
- BS in Information Systems
About TraceLink, Inc
tracelink.comTraceLink powers the world’s largest digital network for agentic supply chain orchestration, helping life sciences partners deliver medicines faster, safer, and more reliably to patients. Its cloud-based platform connects manufacturers, contract organizations, wholesalers, pharmacies and regulators to provide serialization, track-and-trace, regulatory compliance, end-to-end visibility and supply orchestration. TraceLink combines networked connectivity, data standards, analytics and automation to detect and resolve disruptions, enforce provenance and accelerate product launches across global, regulated supply chains. Life sciences companies rely on TraceLink for industry-tailored solutions and the scale to manage complex, compliance-driven distribution networks.